A-Soft Reliner
FDA 510(k) K984483 · S & C Polymer GmbH
510(k) numberK984483
Submission
- Device name
- A-Soft Reliner
- Applicant
- S & C Polymer GmbH
Elmshorn, DE - Received
- December 16, 1998
- Decision date
- February 18, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K261802 | Glidewell Denture Base ResinEBI · Traditional | Prismatik Dentalcraft, Inc. | 08/27/2026SE |
| K261626 | UltraPrint Flexible Denture UVEBI · Traditional | Guangzhou Heygears IMC., Inc. | 08/13/2026SE |
| K262681 | NanoCeram ResinEBI · Traditional | 3BFAB Teknoloji A.S. | 07/31/2026SE |
| K262300 | Denture Base Resin V2EBI · Abbreviated | Formlabs Ohio, Inc. | 07/08/2026SE |
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| K253365 | LuxCreo Flexible Partial Denture ResinEBI · Traditional | LuxCreo, Inc. | 11/25/2025SE |
| K253681 | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard…EBI · Traditional | Graphy, Inc. | 11/21/2025SE |
| K253324 | UltraPrint-Dental Denture UVEBI · Traditional | Guangzhou Heygears IMC., Inc. | 11/20/2025SE |
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| K081702 | Carboxylate Cem, Phosphate CemEMA · Traditional | 09/05/2008SE |
| K042614 | S&C-Self Etch Pr-BondKLE · Traditional | 11/22/2004SE |
| K031420 | S & C -Bracket AdhesivesDYH · Traditional | 08/20/2003SE |
| K012767 | S & C Hydro Vinyl Polysiloxane Impression MaterialELW · Traditional | 11/01/2001SE |
| K011277 | Hard RelinerEBI · Traditional | 06/26/2001SE |
| K011431 | Resin CemEMA · Traditional | 06/11/2001SE |
Questions and answers
When was A-Soft Reliner cleared by the FDA?
A-Soft Reliner (K984483) received a 510(k) decision of Substantially Equivalent on February 18, 1999, 64 days after the submission was received.
What is the product code of K984483?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.